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Fukuda Denshi HLX-561 Operation Manual

Telemetry transmitter module
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EXHIBIT D: User Manual
FCC ID DV8HLX561

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Summary of Contents for Fukuda Denshi HLX-561

  • Page 1 EXHIBIT D: User Manual FCC ID DV8HLX561...
  • Page 2 Telemetry Transmitter Module HLX-561 Operation Manual Read this manual prior to use of the HLX-561. Store this operation manual in an easily accessible place near the unit for future reference.
  • Page 3 NOTE: Only a physician or a person under the guidance of a physician can use this device. Copyright © 2001 by Fukuda Denshi Co., Ltd. No part of this document may be copied or transmitted in any form without the prior written permission of Fukuda Denshi Co., Ltd. Printed in Japan...
  • Page 4 • Any obstruction such as reinforced concrete or large metallic surfaces between the receiver and the transmitter can affect reception. If problems occur contact your local Fukuda Denshi service representative. • When the low battery alarm is present at the central monitor, charge...
  • Page 5 CAUTION Users are advised to periodically contact the FCC or specified frequency coordinator and determine if other or your transmitter frequencies that may cause interference. CAUTION The manufacturers, installers and users of Wireless Medical Telemetry System equipment are cautioned that the operation of this equipment could result in harmful interference to other nearby medical devices.

  • Page 6: Safety Information And Messages

    Fukuda Denshi. Before use, read this operation manual thoroughly for correct handling and operation. If you are familiar with a similar type of product, it is recommended this operation manual be read and understood since the HLX-561 has unique operation and handling methods. Safety Information and Messages Be sure to observe the warning and cautionary messages related to important safety information.
  • Page 7 Contents described here are general safety considerations to be taken for proper operation of medical electrical equipment and for the safety of both the patient and operator. Safety considerations specific to the use of the HLX-561 telemetry transmission module are described on the next page. CAUTION 1.
  • Page 8 Contact your nearest Fukuda representative and label the device as "OUT OF ORDER". 7. Do not disassemble or attempt service on the equipment. Contact your nearest Fukuda Denshi representative for service. 8. Maintenance and Inspection • Be sure to perform periodic inspection of the equipment and accessories.
  • Page 9 CAUTION 9. When using an electrosurgical unit or defibrillator in conjunction with this equipment, take care of the following. • The high-frequency energy produced by electrosurgy equipment may result in burns to the patient or possible damage to the equipment. Be sure to observe the precautionary instructions described in the operation manual of the electrosurgical unit.

  • Page 10: Table Of Contents

    Safety Considerations in Using Medical Electrical Equipment 1. General Description 2. Controls and Indicators 3. Mounting the HLX-561 to the Bedside Monitor Mounting into the DS-5100 Mounting into the DS-5300 4. Setting the Receiving Channel of the Monitor 5. Cleaning, Sterilization and Disinfection 6.

  • Page 12: General Description

    The HLX-561 is a telemetry transmission module to transmit physiological parameters monitored by a bedside monitor in the DS-5000 series via wireless technology. Thus, the HLX-561 allows the user to configure an integrated telemetry patient monitoring system in combination with a central telemetry receiver and central monitor such as the DS-5800N.

  • Page 13: Controls And Indicators

    2. Controls and Indicators Antenna Channel Label Connector Mounting Fixture (option) Wire Adapter Mounting Hole Wire Adapter (option) Connector (option)
  • Page 14 Wire Adapter OA-287 (option) Allows for mounting the HLX-561 onto a bedside monitor. Connector (option) Allows for external connection of the HLX-561 to the bedside monitor. Connect to the F-LINK connector of the bedside monitor. Mounting Fixture (option) For mounting the HLX-561 into the bedside monitor. The illustration...

  • Page 15: Mounting The Hlx-561 To The Bedside Monitor

    Mounting the HLX-561 to the Bedside Monitor Described here are the procedures for mounting the HLX-561 to the DS-5100 and DS-5300 as typical bedside monitors. If the radio channel is changed, it is recommended the channel label be changed in advance.
  • Page 16 HLX-561. Remove the cap which covers the antenna hole in the top of HLX-561 transmission module housing cover. Place the HLX-561 into the housing, taking care not to...
  • Page 17 FCC for the Wireless Medical Telemetry Service. To check the system, and verify proper transmission from the HLX-561 to the telemetry receiver, check the central receiver and monitor to ensure the waveforms and alphanumeric data are properly displayed.

  • Page 18: Mounting Into The Ds-5300

    Connect the optional HLX-561 OA-287 adapter to the HLX-561, connector to connector. Attach the adapter to the HLX-561 with the accessory screw OA-287 (M2.6 x 8). Attach the optional mounting fixture onto the HLX-561 with two accessory screws (M2.6...
  • Page 19 Connect the cable from the OA-287 to the F-LINK connector of DS-5300. Reconnect the power cord and turn the DS-5300 ON. Select the telemetry channel from the telemetry set-up display on the DS-5300. For details on the telemetry channel set-up procedure, refer to the operation manual for to the DS-5300.
  • Page 20 To check the system, and verify proper transmission from the HLX-561 to the telemetry receiver, check the central receiver and monitor to ensure the waveforms and alphanumeric data are properly displayed. The wireless network system is now functioning properly.

  • Page 21: Setting The Receiving Channel Of The Monitor

    Setting the Receiving Channel of the Monitor Select the telemetry receiver channel to match that of the telemetry transmission module. The monitor will display the channel number. If the transmission module has a different group code than that of the receiver, set the telemetry receiver group code to correspond to the telemetry transmission module.

  • Page 22: Cleaning, Sterilization And Disinfection

    Such chemical solutions may damage the resin casing. Sterilization and Disinfection For Disinfection, wipe the HLX-561 and accessories using a gauze or sanitary cotton moistened with inert soap or alcohol. Do not moisten allow moisture inside of the connector to avoid contact failure.

  • Page 23: Maintenance And Inspection

    6. Maintenance and Inspection To maintain the safety and reliable functionality and performance of the HLX-561, it is preferable to perform routine and periodic inspections before use. A recommendation is described in this section. Failure to perform routine maintenance and inspection may void the responsibility of Fukuda Denshi.
  • Page 24 Routine Inspection Record Inspection Date: Inspected by: Location: Model: HLX-561 Serial No.: Purchase Date: Items Inspection Judgement criteria Judgement Check the external No abnormalities appearance for scratches, breaks, cracks, loose External screws, or labels. Pass/Fail appearance Check the antenna for bends or breaks.

  • Page 25: Specifications

    7. Specifications Transmitting Information (will depend on bedside monitor used) : ECG × 1, 5 additional waveforms (e.g. Waveforms Respiration, pulse, 2 blood pressure waveforms) Numeric Parameters : NIBP, SpO , Temp 1, Temp 2, BP1, BP2, Heart Rate, Respiration Rate, etc. Status Information : Low Battery, Electrode fail, Group code (64 types), Alarm, Alarm suspend,...
  • Page 26 Dimensions and Weight : 61.5(W) × 108.5(H) × 20.5(D) mm Dimensions Weigh : Approximately 100 grams Environmental Conditions Operating Temperature : 10 to 40 °C Operating Humidity : 30 to 85 %R.H. no dew condensation : −10 to 60 °C Storage Temperature : 30 to 95 %R.H.(at 60 °C) Storage Humidity...

  • Page 27: Accessories

    8. Accessories To ensure the HLX-561 will perform to its published specifications, use only those accessories specified by Fukuda Denshi. When ordering spare parts or accessories, specify the part name and model number. Standard Accessories Item Model Q'ty Remarks Operation Manual Optional Accessories The following item is not included in standard accessories.
  • Page 28 Head office : 39-4, Hongo 3-chome, Bunkyo-ku, Tokyo, Japan Phone : -81-3-3815-2121 Telex : 23498 FUKUMED J Fax : -81-3-5684-3791 4L2869 200102...

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